Feature

Working Together to promote High Quality Research

Summary

The ever vibrant Institute of Clinical Research’s Annual Spring Meeting rolled into Birmingham at the end of March, bigger and better than ever. Riding in the vanguard were keynote speakers Dr. Tom Mc

The ever vibrant Institute of Clinical Research’s Annual Spring Meeting rolled into Birmingham at the end of March, bigger and better than ever. Riding in the vanguard were keynote speakers Dr. Tom McKillop, Chief Executive of AstraZeneca and Lord Hunt of Kingsheath, Parliamentary Under Secretary of State for Health in the Lords. The Co-Chairmen of PICTF (The Pharmaceutical Industry Competitiveness Task Force) addressed the conference on the topic ‘Working Together to promote High Quality Research’, which, despite the abundance of new labour buzz words in it’s title managed to both interest and educate an audience for whom Monday morning was perhaps that bit too early.
Lord Hunt led the way with a speech that, despite including the line “you may well have seen the full copy of the PICTF report” seemed remarkably in touch with the needs and concerns of the assembled group. His quote from the Prime Minister though, “the UK Pharmaceutical industry is one of our most important and most successful industries. It’s products benefit people here and around the world and it makes a substantial contribution to our economic welfare,” was remarkably bland. (Try substituting any of the following for ‘Pharmaceutical’ and see how it reads ‘Oil’, ‘Aerospace’, ‘Music’, ‘Novelty Tea Towel’) and hardly the kind of rallying call to a conference of Clinical Research professionals concerned that their jobs might soon be fleeing to the US. Both speakers were keen to share statistics with the audience, particularly those which reiterated the ‘important and successful’ and ‘substantial contribution to our economic welfare’ parts of the Prime Minister’ soundbite. Lord Hunt weighed in with the fact that the contribution of the pharma industry to the UK’s balance of trade was over 2 billion per annum and that overall the UK is the second most innovative producer of new pharmaceutical products after the USA, Dr McKillop told the assembled throng that there was over £3 billion pounds spent on research in the UK per annum, and that 53% of that was on Clinical Research. But the crux of both speeches seemed to be a resigned attitude to the key aspect of the second of that statistical foursome. The UK is second at best in the pharmaceutical market, and the USA, regardless of committees, industry focus groups or even task forces will continue to lead the way.
This situation is not unique to the pharmaceutical industry, indeed Pharmaceuticals is an area where the UK competes more successfully than in most others but the sheer power and wealth of the insurance driven US health market makes it magnetically attractive for companies seeking regulatory approval for new products. Indeed fears over the strength of the US industry were, according to Dr McKillop, the galvanising factor in the decision by the CEOs of AstraZeneca, Glaxo Wellcome and SmithKline Beecham to approach the Prime Minister with their concerns, a decision that led to the formation of PICTF. FDA approval will always come before NICE recommendations in a pharmaceutical companies planning, and probably even before any blanket EMEA recommendation that might eventually be accepted by all European countries. Dr McKillop himself included the line ‘These are clear signs that the competitiveness of the European pharmaceutical industry is weakening.’ A more forthright synopsis couldn’t have been asked for. Faced with this it was difficult to see what any policy of closer co-operation, working together or industry-government partnership could possibly do to address the situation.
Aside from the negativity attached to the growing dominance of the US over the pharmaceutical industry as a whole there were positive messages for the average Clinical Research professional to take away from the keynote speeches. Lord Hunt talked extensively about the new spirit of co-operation currently being fostered between industry and the NHS with regards to Clinical Trials and took the opportunity of the conferences start to announce an R&D partnership agreement between the NHS/Department of Health and the Pharmaceutical industry. Details of the agreement were thin on the ground, a need to educate the public about clinical research and enhance the willingness of patients and carers to take part was mentioned, an admirable target but one that is a media minefield. The partnership document also includes an aim to uphold the requirements of the EU directive on Clinical Trials. The directive, which has to come into force in the UK by May 2004 will mark a major change for the pharmaceutical industry as it includes a requirement for MCA authorisation of Healthy Volunteer studies. It is commendable on the part of both government and industry that they are looking to address this change sooner rather than later. Lord Hunt also made passing mention of a generic trials agreement being in the advanced stage of the drafting process. Such an agreement would be a huge boon to the industry, leading as it would to the avoidance of repetitive re-negotiation of contracts every time a new trial is proposed by a company, saving all concerned time and, hence money.
A number of questions were posed to both the speakers and the post speech debate was both lively and friendly with questions being fielded by the speakers themselves and members of the audience with particular expertise, of particular note was the prospect of further co-operation in Clinical Research projects between the NHS and big Pharma a prospect which, if rhetoric is backed up by concerted effort, would benefit both parties in terms of cost savings. Perhaps the most pertinent quote to come out of the entire session, though was Dr McKillop’s statement, “Innovation and competition are the lifeblood of the pharmaceutical industry,” the government must create an environment that fosters this innovation, despite the inevitable financial constraints of the NHS, without it the British pharmaceutical industry and the clinical research that is dependent on it won’t be able to offer any competition to the growing hegemony of the US.

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